HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL)today provided an update
on the status of its resolution of the previously disclosed warning
letter issued by the U.S. Food and Drug Administration (FDA) covering
its Hayward manufacturing facility. Late last year, Impax received an
acknowledgement letter from the FDA stating that it had received a
complete response from Impax to the warning letter. However, a
satisfactory re-inspection is required to close out the warning letter
and the re-inspection by the FDA has not occurred to date. Therefore,
the Company’s previously stated goal for completing the closing out of
the warning letter before the end of February 2012 may not occur. Until
such re-inspection is completed and the warning letter is closed out,
approval of the Company’s pending drug applications listing the Hayward
manufacturing facility as a manufacturing location may be withheld by
the FDA.

“We worked as quickly and diligently as possible to ensure we addressed
all FDA concerns, and look forward to a timely resolution,” said Larry
Hsu, Ph.D., president and CEO, Impax Laboratories. “At the same time, we
have been successfully executing our growth strategy, including pursuing
external growth opportunities, further advancing our generic and brand
R&D pipeline, and servicing our customers. Our focus on achieving these
objectives is evident in several recent positive events, including
obtaining a long-term licensing agreement for Zomig®, advancing our
pipeline with the filing of a New Drug Application for IPX066 and
submitting 11 Abbreviated New Drug Applications in 2011.”

As part of its Global Quality Improvement Program, the Company said it
has revised its Standard Operating Procedures, made key staffing
changes, revalidated manufacturing processes, conducted additional
training, and purchased and validated new equipment.

Hsu added, “Improving the operation of all of our production facilities
and company-wide quality systems has strengthened our Company, and
continuous improvement will remain a top priority. We appreciate the
communication and guidance provided by the FDA throughout this process
and look forward to their re-inspection of our Hayward facility.”

Yesterday Impax received notice from the FDA that it has forfeited
exclusivity on its generic version of Doryx 150mg.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical
company applying its formulation expertise and drug delivery technology
to the development of controlled-release and specialty generics in
addition to the development of branded products. Impax markets its
generic products through its Global Pharmaceuticals division and markets
its branded products through the Impax Pharmaceuticals division.
Additionally, where strategically appropriate, Impax has developed
marketing partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a full
range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web site
at: www.impaxlabs.com.

To the extent any statements made in this news release contain
information that is not historical, including the statements under the
heading “2011 Financial Outlook,” these statements are forward-looking
in nature and express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and operating
income, the ability to successfully develop and commercialize
pharmaceutical products, reductions or loss of business with any
significant customer or a reduction in sales of any significant product,
the impact of competition, the ability to sustain profitability and
positive cash flows, any delays or unanticipated expenses in connection
with the operation of the Taiwan facility, the effect of foreign
economic, political, legal and other risks on operations abroad, the
uncertainty of patent litigation, consumer acceptance and demand for new
pharmaceutical products, the difficulty of predicting Food and Drug
Administration filings and approvals, the inexperience of the Company in
conducting clinical trials and submitting new drug applications, the
ability to successfully conduct clinical trials, reliance on alliance
and collaboration agreements, the availability of raw materials, the
ability to comply with legal and regulatory requirements governing the
pharmaceuticals and healthcare industries, the regulatory environment,
the ability to protect the Company’s intellectual property, exposure to
product liability claims and other risks described in the Company’s
periodic reports filed with the Securities and Exchange Commission.
Forward-looking statements speak only as to the date on which they are
made, and Impax undertakes no obligation to update publicly or revise
any forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.